LOW-PROFILE WEARABLE MEDICAL DEVICE
Wearable medical devices are provided. An exemplary wearable medical device includes a printed circuit board assembly (PCBA) comprising a dielectric layer having a top surface and conductive features on the top surface of the dielectric layer. Further, the exemplary wearable medical device includes a top housing mounted directly to the top surface of the PCBA. Also, the wearable medical device includes a power source located between the top housing and the PCBA. The top housing and the dielectric layer of the PCBA encapsulates the conductive features and power source and define an outer surface of the wearable medical device.
The present technology is generally related to wearable medical devices, and more particularly to low-profile wearable medical devices having reduced housing components.
BACKGROUNDThe use of wearable medical devices, such as continuous glucose monitor (CGM) devices, is increasing. Wearable medical devices may provide biometric monitoring and reporting relating to the health of a wearer. In many health monitoring applications, a wireless sensor in the wearable medical device is attached directly to or under the user's skin to measure certain data. This measured data can then be utilized for a variety of health-related applications.
Wearable medical devices allow for continuous monitoring of a user's health. However, due to the continuous nature of the monitoring, users are particularly concerned about comfort and the possible obtrusiveness of these devices in certain situations.
Accordingly, it is desirable to provide a low-profile wearable medical device with a reduced height. Also, it may be desirable to provide a wearable medical device with a smaller footprint. In addition, it is desirable to provide a wearable medical device having fewer components. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.
BRIEF SUMMARYThe subject matter of this disclosure generally relates to a wearable medical device including a printed circuit board assembly (PCBA) comprising a dielectric layer having a top surface and conductive features on the top surface of the dielectric layer, a top housing mounted directly to the top surface of the PCBA, and a power source located between the top housing and the PCBA; wherein the top housing and the dielectric layer of the PCBA encapsulates the conductive features and power source and define an outer surface of the wearable medical device.
In an exemplary wearable medical device, the PCBA has a bottom surface, and the wearable medical device further includes an adhesive on the bottom surface for adhering the wearable medical device to a user's skin.
In an exemplary wearable medical device, the dielectric layer of the PCBA is a rigid member. In another exemplary wearable medical device, the dielectric layer of the PCBA is a flexible member.
In an exemplary wearable medical device, the top housing is a rigid shell. In another exemplary wearable medical device, the top housing is a flexible substrate.
In an exemplary wearable medical device, the top housing is connected directly to the PCBA, thereby forming a continuous peripheral seal therebetween.
An exemplary wearable medical device further includes an antenna electrically connected to the PCBA and located between the PCBA and the top housing. An exemplary antenna is a stamped antenna, additive-manufactured antenna, or flexible electronic trace antenna.
In an exemplary wearable medical device, the top housing has an inner surface facing the PCBA, and the wearable medical device further includes an antenna mounted on the inner surface of the top housing and an antenna connector interconnecting the antenna and the PCBA.
In an exemplary wearable medical device, the top housing has an outer surface and the wearable medical device further includes an antenna mounted on the outer surface of the top housing, a conductive member embedded in the top housing and electrically connected to the antenna, and an antenna connector electrically interconnecting the conductive member and the PCBA. Further, an exemplary antenna on the outer surface of the top housing is located between the top housing and a protective cover.
In one aspect, the present disclosure provides a wearable medical device including a bottom housing, a top housing mounted to the bottom housing and defining an encapsulated volume therebetween, an integrated circuit in the bottom housing, a battery cell located in the encapsulated volume and electrically connected to the integrated circuit, and a sensor having an internal portion located in the encapsulated volume and extending through the bottom housing to an external portion. An exemplary sensor is a glucose sensor.
In an exemplary wearable medical device, the bottom housing has a bottom surface and the wearable medical device further includes an adhesive on the bottom surface for adhering the wearable medical device to a user's skin.
In an exemplary wearable medical device, the top housing is connected directly to the bottom housing, thereby forming a continuous peripheral seal therebetween.
A wearable medical device further includes an antenna located in the encapsulated volume and electrically connected to the integrated circuit.
In an exemplary wearable medical device, the top housing has an inner surface facing the bottom housing, and the wearable medical device further includes an antenna mounted on the inner surface of the top housing and an antenna connector interconnecting the antenna and the integrated circuit.
In an exemplary wearable medical device, the top housing has an outer surface and the wearable medical device further includes an antenna mounted on the outer surface of the top housing; a conductive member embedded in the top housing and electrically connected to the antenna; and an antenna connector electrically interconnecting the conductive member and the integrated circuit. An exemplary antenna on the outer surface of the top housing is located between the top housing and a protective cover.
In another aspect, the disclosure provides a method for fabricating a wearable medical device. The exemplary method includes fabricating an integrated circuit on a dielectric layer, positioning a power source over the dielectric layer, and connecting a top housing to the dielectric layer to define an encapsulated volume between the top housing and the dielectric layer, wherein the integrated circuit and the power source are located in the encapsulated volume.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
In addition, certain terminology may also be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, and “side”, describe the orientation and/or location of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second”, and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings.
As described herein, embodiments are provided for reducing the height of wearable medical devices as compared to commercially available devices having interconnected top and bottom housings that encapsulate and protect internal components such as electronics. Embodiments herein provide for reducing the height of wearable medical devices by eliminating the use of a dedicated bottom housing. Instead, embodiments herein may utilize as a bottom housing the dielectric layer of a printed circuit board assembly (PCBA). Specifically, the dedicated bottom housing is replaced with a member that is already needed for operation of the wearable medical device. Further, certain embodiments herein provide for locating the antenna for the medical device at an increased distance from the wearer's skin when being worn.
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In an exemplary embodiment, the top housing 20 is mounted over and directly sealed to the PCBA 25, and specifically to the dielectric layer 26. As shown most clearly in
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Embodiments of sensors 50 provided herein use biological elements to convert a chemical analyte in a matrix into a detectable signal. In certain embodiments, a sensor 50 of the type presented here is designed and configured for subcutaneous operation in the body of a patient. An exemplary sensor 50 is a glucose sensor. The sensor 50 includes electrodes that are electrically coupled to a suitably configured electronics module that applies the necessary excitation voltages and monitors the corresponding electrical responses (e.g., electrical current, impedance, or the like) that are indicative of physiological characteristics of the body of the patient. For the embodiment described here, the sensor 50 may include a working electrode, reference electrode and counter electrode. An exemplary working electrode has includes a platinum layer, an analyte sensing layer over the platinum layer and including a catalyst or reagent or enzyme, such as glucose oxidase (GOx), a protein layer over the analyte sensing layer, an adhesion promoting layer over the protein layer, and an overlying selective permeable membrane. The working electrode may work according to the following chemical reactions:
The glucose oxidase (GOx) is provided in the sensor 50 and is encapsulated by a semipermeable membrane adjacent the working electrode. The semipermeable membrane allows for selective transport of glucose and oxygen to provide contact with the glucose oxidase. The glucose oxidase catalyzes the reaction between glucose and oxygen to yield gluconic acid and hydrogen peroxide (Equation 1). The H2O2 then contacts the working electrode and reacts electrochemically as shown in Equation 2 under electrocatalysis by the working electrode. The resulting current can be measured by a potentiostat. These reactions, which occur in a variety of oxidoreductases known in the art, are used in a number of sensor designs.
When the sensor electrodes are placed at a subcutaneous location at a selected site in the body of a user, the sensor electrodes are exposed to the user's bodily fluids such that they can react in a detectable manner to the physiological characteristic of interest, e.g., blood glucose level. In certain embodiments, the sensor electrodes may include one or more working electrodes, counter electrodes, and reference electrodes. For the embodiments described here, the sensor electrodes employ thin film electrochemical sensor technology of the type used for monitoring blood glucose levels in the body. Further description of flexible thin film sensors of this general type are found in U.S. Pat. No. 5,391,250, entitled METHOD OF FABRICATING THIN FILM SENSORS, which is herein incorporated by reference. In other embodiments, different types of implantable sensor technology, such as chemical based, optical based, or the like, may be used.
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In addition to the wearable medical device 100, methods for fabricating wearable medical devices are disclosed. In an exemplary method, integrated circuits or conductive features 30 are fabricated over, on and/or in a dielectric layer 26. Further, a power source 54 and portion of a sensor 50 are positioned over the dielectric layer 26. The method also includes connecting a top housing 20 to the dielectric layer 26 to define an encapsulated internal volume 44 between the top housing 20 and the dielectric layer 26. In the exemplary method, the integrated circuit 30, power source 54, and portion of sensor 50, as well as other internal features, are located in the encapsulated internal volume 44. The wearable medical device 100 may be positioned at a desired location on a wearer's skin and adhered thereto, such as with adhesive layer 34. Further, a probe or needle may be advanced through the central opening 40 in the wearable medical device 100, to place the distal portion 51 of the sensor 50 at a desired location, such as under the skin.
As described herein, a wearable medical device 100 is provided with a reduced height by eliminating a dedicated bottom housing from the structure of the device 100. Instead, a dielectric layer 26 of a PCBA 25 serves as the bottom housing to which the top housing is sealed. Further, embodiments herein provide for locating the antenna from the skin at an increased distance despite the elimination of a dedicated bottom housing. For example, in certain embodiments, the antenna may be located in the internal volume 44 immediately below the inner surface 19 of the top housing 20, located on the inner surface 19 of the top housing 20, or located in or on the outer surface 24 of the top housing 20.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.
Claims
1. A wearable medical device comprising:
- a printed circuit board assembly (PCBA) comprising a dielectric layer having a top surface and conductive features on the top surface of the dielectric layer, wherein the dielectric layer has a bottom surface;
- an adhesive located on the bottom surface of the dielectric layer for adhering the wearable medical device to a user's skin;
- a top housing mounted directly to the top surface of the PCBA; and
- a power source located between the top housing and the PCBA; wherein the top housing and the dielectric layer of the PCBA encapsulate the conductive features and power source and define an outer surface of the wearable medical device.
2. The wearable medical device of claim 1 wherein the top housing extends laterally to an outer periphery, and wherein the adhesive extends laterally from under the top housing to outside the periphery of the top housing.
3. The wearable medical device of claim 1 wherein the medical device has an outermost lateral surface extending from the bottom surface of the dielectric layer to an upper surface of the top housing, wherein the outermost lateral surface is comprised of only the dielectric layer and the top housing.
4. The wearable medical device of claim 1 wherein the dielectric layer of the PCBA is a flexible member.
5. The wearable medical device of claim 1 wherein the top housing is formed with a central portion surrounded by a substantially vertical sidewall portion that terminates at an end mounted directly to the top surface of the PCBA, and wherein the sidewall portion includes a substantially horizontal step surface for applying a downward force thereon to seal the wearable medical device to a user's skin.
6. The wearable medical device of claim 1 wherein the top housing is a flexible substrate extending from a first end to a second end and having a bottom side and a top side opposite of the bottom side, wherein the bottom side of the flexible layer is mounted directly to the top surface of the dielectric layer.
7. The wearable medical device of claim 1 wherein the PCBA has an outer side edge, and wherein the top housing is connected directly to the top surface and the outer side edge of the PCBA, thereby forming a continuous peripheral seal therebetween.
8. The wearable medical device of claim 1 further comprising an antenna electrically connected to the PCBA and located between the PCBA and the top housing, wherein the antenna comprises a vertical portion connected to the PCBA and a horizontal portion distanced from and extending in a direction parallel to the PCBA.
9. The wearable medical device of claim 1 further comprising:
- an antenna located between the PCBA and the top housing, wherein the antenna is a stamped antenna, additive-manufactured antenna, or flexible electronic trace antenna, and wherein the antenna is located within a plane distanced from and parallel to the PCBA; and
- an antenna connector electrically connecting the conductive member and the PCBA.
10. The wearable medical device of claim 1 wherein the top housing has an inner surface facing the PCBA, and wherein the wearable medical device further comprises:
- an antenna exclusively located on the inner surface of the top housing; and
- an antenna connector interconnecting the antenna and the PCBA.
11. The wearable medical device of claim 1 wherein the top housing has an outer surface, and wherein the wearable medical device further comprises:
- an antenna exclusively located on the outer surface of the top housing;
- a conductive member embedded in the top housing and electrically connected to the antenna; and
- an antenna connector electrically interconnecting the conductive member and the PCBA.
12. The wearable medical device of claim 11 wherein the antenna on the outer surface of the top housing is located between the top housing and a protective cover.
13. A wearable medical device comprising:
- a printed circuit board assembly (PCBA) comprising a dielectric layer serving as a bottom housing for the wearable medical device and an integrated circuit;
- a top housing having a horizontally-extending central portion surrounded by a sidewall portion, wherein the sidewall portion is mounted directly to the PCBA, and wherein an encapsulated volume is defined within the horizontally-extending central portion, the sidewall and the PCBA;
- a battery cell located in the encapsulated volume and electrically connected to the integrated circuit;
- a sensor having an internal portion located in the encapsulated volume and extending through the bottom housing to an external portion; and
- an antenna on the horizontally-extending central portion of the top housing.
14. The wearable medical device of claim 13 wherein the PCBA has a bottom surface, and wherein the wearable medical device further comprises an adhesive on the bottom surface for adhering the wearable medical device to a user's skin.
15. The wearable medical device of claim 13 wherein the top housing is connected directly to a top surface of the PCBA, thereby forming a continuous peripheral seal therebetween.
16. The wearable medical device of claim 13 wherein every portion of the antenna is located outside of the encapsulated volume.
17. The wearable medical device of claim 13 wherein the horizontally-extending central portion of the top housing has an inner surface facing the bottom housing, wherein the antenna is mounted on the inner surface of the horizontally-extending central portion of the top housing; and wherein the wearable medical device further comprises an antenna connector interconnecting the antenna and the integrated circuit.
18. The wearable medical device of claim 13 wherein the horizontally-extending central portion of the top housing has an outer surface, wherein the antenna is mounted on the outer surface of the horizontally-extending central portion of the top housing; and wherein the wearable medical device further comprises:
- a conductive member embedded in the top housing and electrically connected to the antenna; and
- an antenna connector electrically interconnecting the conductive member and the integrated circuit.
19. The wearable medical device of claim 18 wherein the antenna on the outer surface of the horizontally-extending central portion of the top housing is located between the top housing and a protective cover.
20. The wearable medical device of claim 13 wherein the sensor is a glucose sensor.
21. A method for fabricating a wearable medical device, the method comprising:
- fabricating an integrated circuit on a dielectric layer;
- positioning a power source over the dielectric layer;
- connecting a top housing to the dielectric layer to define an encapsulated volume between the top housing and the dielectric layer, wherein the integrated circuit and the power source are located in the encapsulated volume; and
- fixing an adhesive layer to a bottom surface of the dielectric layer, wherein the adhesive extends laterally beyond an outer periphery of the top housing and laterally beyond an outer periphery of the dielectric layer.
Type: Application
Filed: Oct 30, 2020
Publication Date: May 5, 2022
Patent Grant number: 11534086
Inventors: Ellis Garai (Studio City, CA), James E. Burgett (Maple Grove, MN), Claire F. Ferraro (Plymouth, MN)
Application Number: 17/086,171